Patient-centred clinical-study endpoints derived using digital health technologies

Code: 34259 | Identifier Code: HORIZON-JU-IHI-2024-08-04-two-stage | Programme name: Innovative Health Initiative | Start submission calls: 25/06/2024 | End submission calls: 23/04/2025

The topic aims to develop a unified framework and consensus-based recommendations for using multiple types of patient-centred information to support the use of DHT-derived endpoints to demonstrate therapeutic benefit. This will ensure that therapies addressing patients’ needs are approved for use and reimbursed at levels that reflect the value of the therapies to patients.

Modelling regulatory sandbox mechanisms and enabling their deployment to support breakthrough innovation

Code: 34257 | Identifier Code: HORIZON-JU-IHI-2024-08-03-two-stage | Programme name: Innovative Health Initiative | Start submission calls: 25/06/2024 | End submission calls: 23/04/2025

The overall aim of this IHI topic is to contribute to the progression and successful implementation of regulatory sandboxes for healthcare innovations by developing a comprehensive and shared understanding of their value and process of implementation. The topic should also enable the development of a cross-sectoral community of stakeholders including pharma and medical device companies, regulators, and health technology assessment bodies (HTAs), among other stakeholders.

The first-stage deadline for the submission of short proposals under all topics is 10 October 2024, 17h00 (Brussels time). The second-stage deadline for the submission of full proposals under all topics is 23 April 2025, 17h00 (Brussels time).

Novel Endpoints for Osteoarthritis (OA) by applying Big Data Analytics

Code: 34255 | Identifier Code: HORIZON-JU-IHI-2024-08-02-two-stage | Programme name: Innovative Health Initiative | Start submission calls: 25/06/2024 | End submission calls: 23/04/2025

The overall aim of this topic is to build a public-private partnership that is able to integrate and leverage the plethora of existing and currently collected data on OA, as well as the increasing insights and expertise gathered over decades of research. Further, the goal is to use a data driven approach to significantly progress the field by leveraging the novel opportunities that have emerged thanks to increased computing power and innovative methodologies in big data analysis, in order to:

1. integrate different perspectives to improve the understanding of osteoarthritis as a complex disease;
2. foster progress towards regulatory validation of patient-relevant endpoints to measure and predict OA disease progression as well as alternative endpoints to measure response to treatment;
3. allow predictive modelling while actively seeking feedback to incorporate the perception of patients, care givers, primary care physicians and regulators.

The first-stage deadline for the submission of short proposals under all topics is 10 October 2024, 17h00 (Brussels time). The second-stage deadline for the submission of full proposals under all topics is 23 April 2025, 17h00 (Brussels time).

A city-based approach to reducing cardiovascular mortality in Europe

Code: 34252 | Identifier Code: HORIZON-JU-IHI-2024-08-01-two-stage | Programme name: Innovative Health Initiative | Start submission calls: 25/06/2024 | End submission calls: 23/04/2025

The focus of this topic is on identifying and creating scalable models, interventions, and practices to enhance the overall efficiency and effectiveness of CVD management based on existing (e.g. Cardio4Cities) or new pilots in up to 5 cities, to build evidence for replication across Europe in different socio-economic conditions. These pilots should propose a good coverage of different locations and contexts in Europe and deliver scalable solutions that can be applied to other cities.

The first-stage deadline for the submission of short proposals under all topics is 10 October 2024, 17h00 (Brussels time). The second-stage deadline for the submission of full proposals under all topics is 23 April 2025, 17h00 (Brussels time).

Clinical validation of biomarkers for diagnosis, monitoring disease progression and treatment response

Code: 32404 | Identifier Code: HORIZON-JU-IHI-2024-07-03-singe-stage | Programme name: Innovative Health Initiative | Start submission calls: 16/01/2024 | End submission calls: 22/05/2024

Technology development or improvements to existing technologies may be required to progress these biomarkers to clinical validation. For example, there are many novel and highly innovative technologies in development (e.g. imaging, artificial intelligence (AI), omics markers, phage-based diagnostics in multiple formats among others) and their further development and validation would be a necessary element for validating their detected biomarkers in the clinic.

Furthermore, different healthcare actors (e.g. academics, clinicians, patients, health technology developers and regulators) may have different definitions and expectations on the utilities of biomarkers, and there is a need for an aligned methodological framework for scaling up the clinical validation of candidate biomarkers.

User-centric technologies and optimized hospital workflows for a sustainable healthcare workforce

Code: 32402 | Identifier Code: HORIZON-JU-IHI-2024-07-02-singe-stage | Programme name: Innovative Health Initiative | Start submission calls: 16/01/2024 | End submission calls: 22/05/2024

Technical and data-driven solutions have the potential to support the healthcare workforce, but their adoption has faced many challenges. While AI solutions have been proposed to support clinical decision making, operational optimization, patient empowerment, healthy lifestyle maintenance and population health management, they require further testing and validation.

Projects funded under this theme should develop or improve innovative medical technology solutions. Better integration of existing solutions and emerging technologies into (optimized) hospital workflows will improve treatment outcomes, ease workloads and maintain job satisfaction. Through collaborative design approaches that incorporate end-user feedback, solutions should aim to be ready for integration into real-world hospital environments. Overall, this theme focuses on user-centric technologies and optimized hospital workflows for a sustainable healthcare workforce.

Improving clinical management of heart disease from early detection to treatment

Code: 32399 | Identifier Code: HORIZON-JU-IHI-2024-07-01-singe-stage | Programme name: Innovative Health Initiative | Start submission calls: 16/01/2024 | End submission calls: 22/05/2024

This topic focuses on the improvement of clinical management of heart disease from early detection to treatment.
Heart disease includes structural heart disease (SHD), coronary artery disease (CAD), heart failure (HF) and heart arrythmias, which are common, devastating, and heterogeneous medical conditions causing a high burden in Europe and worldwide.

Development of evidence based practical guidance for sponsors on the use of real-world data / real-world evidence

Code: 32397 | Identifier Code: HORIZON-JU-IHI-2024-06-02-two-stage | Programme name: Innovative Health Initiative | Start submission calls: 16/01/2024 | End submission calls: 10/10/2024

This topic focuses on the development of evidence based practical guidance for sponsors on the use of real-world data / real-world evidence.

The use of real-world evidence to support decision making on the safety of medicinal products is already well established. Much knowledge exists within individual sponsors on these use-cases, but, to date, this has not been leveraged to develop practical guidance which could act as a baseline for future submissions.
To leverage the learning from individual use cases and facilitate the efficient use of RWD/RWE for regulatory, HTA, and payer submissions and to inform healthcare decision-making, structured, evidence-based, and practical guidance is needed.

Support healthcare system resilience through a focus on persistency in the treatment of chronic diseases

Code: 32395 | Identifier Code: HORIZON-JU-IHI-2024-06-01-two-stage | Programme name: Innovative Health Initiative | Start submission calls: 16/01/2024 | End submission calls: 10/10/2024

The scope of this topic is to improve treatment persistency among people living with chronic diseases. According to the MEDI-VOICE project funded by the European Commission, non-adherence to medication accounted for approximately 200 000 deaths annually in the European Union, and according to a World Health Organisation (WHO) report from 2003, around 50 % of people living with a chronic disease do not adhere to the prescribed medication. From a recent analysis by Kvarnström et al (2018), the major barriers for adherence to medication range from a lack of disease knowledge by the patient to logistical barriers like availability of medication and price (see list below), ultimately leading to discontinuation of medication.

Inclusive clinical studies for equitable access to clinical research in Europe

Code: 30264 | Identifier Code: HORIZON-JU-IHI-2023-04-03-two-stage | Programme name: Innovative Health Initiative | Start submission calls: 27/07/2023 | End submission calls: 08/11/2023

This topic aims to develop a multi-faceted, intersectional approach to overcome the multifactorial barriers associated with the recruitment and retention of underserved patient populations in clinical studies and to contribute to transforming the way clinical studies are conducted in Europe. To fulfil this aim, the following activities around the defined themes should be addressed.

Safe & Sustainable by Design (SSbD) packaging and single use device solutions for healthcare products

Code: 30260 | Identifier Code: HORIZON-JU-IHI-2023-04-05-two-stage | Programme name: Innovative Health Initiative | Start submission calls: 27/07/2023 | End submission calls: 08/11/2023

The project is expected to strengthen and make more competitive the European healthcare industry by positioning it at the forefront of the development of medical technologies, products, and services of the future – those that generate less waste, require less waste treatment, have reduced carbon footprints, increased circularity, and other approaches that reduce the environmental impact of healthcare.

It aims to promote the development of new health products by integrating the principles of the Safe & Sustainable by Design (SSbD) framework, from the earliest design stages, and notably for packaging and device design including the end-of-life of a product. In the context of this call, packaging includes primary packaging in direct contact with products (e.g. drugs, medical devices, in vitro diagnostic reagents, etc.) and secondary packaging made of plastic polymer materials – excluding secondary and tertiary cardboard packaging.

Patient-centric blood sample collection to enable decentralised clinical trials and improve access to healthcare

Code: 30255 | Identifier Code: HORIZON-JU-IHI-2023-04-02-two-stage | Programme name: Innovative Health Initiative | Start submission calls: 27/07/2023 | End submission calls: 08/11/2023

This topic is focused on patient-centric blood sample collection to enable decentralised clinical trials and improve access to healthcare.

The overall aim of the project generated from this topic is to create and validate the infrastructure and logistics for blood collection by the patient and/or caregiver at home as a healthcare tool and an alternative to the current gold standard venous blood for routine clinical assays. This project will employ only commercially available CE-marked microsampling devices, according to their intended use.

The development of new devices for blood sampling or of new clinical assays / analytes is not the focus of this project, and no new clinical assays will be evaluated.

Establishing novel approaches to improve clinical trials for rare and ultra-rare diseases

Code: 30252 | Identifier Code: HORIZON-JU-IHI-2023-04-04-two-stage | Programme name: Innovative Health Initiative | Start submission calls: 27/07/2023 | End submission calls: 08/11/2023

This topic is focused on establishing novel approaches to improve clinical trials for rare and ultra-rare diseases.  The topic aims to unravel roadblocks on the current clinical development pathways and deliver methodological solutions for innovative clinical trial designs and analyses, including regulatory considerations.

Expanding translational knowledge in minipigs: a path to reduce and replace non-human primates in non-clinical safety assessment

Code: 30249 | Identifier Code: HORIZON-JU-IHI-2023-04-01-two-stage | Programme name: Innovative Health Initiative | Start submission calls: 27/07/2023 | End submission calls: 08/11/2023

The overall objective of this topic is to characterise the minipig for use in R&D of new therapeutics and innovative medical technologies. The knowledge generated in this proposal may facilitate innovative health solutions and improve disease understanding and human predictions. The goal is to advance biomedical R&D by generating background scientific data to evaluate if the minipigs could be a viable and feasible alternative to NHPs in key therapeutic areas, with a special focus on translatability from minipigs to humans.

Sustainable circular development and manufacturing of healthcare products and their quantitative environmental impact assessment

Code: 30247 | Identifier Code: HORIZON-JU-IHI-2023-04-06-two-stage | Programme name: Innovative Health Initiative | Start submission calls: 27/07/2023 | End submission calls: 08/11/2023

This project will focus on the standardisation and harmonisation of assessing and scoring the environmental performance of systems across industry: healthcare and API manufacturing by chemical and biotech companies.
They have developed a strong commitment to sustainability by design approaches over the past years with individually developed life cycle assessment methodologies to evaluate the environmental impact of their respective process developments and improvements. All methodologies lack a common framework of metrics and quantitative sets of descriptors to allow comparability of identical unit operations with different assessment systems.

This topic will focus on sustainable circular development and manufacturing of healthcare products and their quantitative environmental impact assessment.

Accelerating the implementation of New Approach Methodologies and other innovative non-animal approaches for the development, testing and production of health technologies

Code: 30231 | Identifier Code: HORIZON-JU-IHI-2023-05-01 | Programme name: Innovative Health Initiative | Start submission calls: 27/07/2023 | End submission calls: 16/01/2024

There is a need to foster progress towards new alternatives (e.g. synthetic matrix, recombinant proteins, optimisation of production processes via artificial intelligence) to reduce the overall number of animals that are bred for these purposes.

NAMs and other innovative non-animal approaches have high potential to improve the development and/or production of health technologies, while contributing to the reduction and replacement of the use of animals. Recent improved biological knowledge, technological advances, computer simulations and innovative non‑animal approaches and methods – e.g. organoids, complex 3D cell models, microphysiological systems, in silico models, non-animal derived antibodies and other biomolecules provide the opportunity to move forward with safer and more effective tools for protecting human health and preventing/treating diseases that would in parallel entail an improvement of animal to human translation or better production processes, as well as helping progress towards the replacement of animals used in biomedical research in general.

The current topic seeks to address these challenges by exploiting the latest relevant scientific advancements to develop NAMs and other non-animal approaches, which could be more readily available and more efficient than those involving animals, and which should improve either the development, including efficacy and safety assessment, of new health technologies for infectious/non-communicable diseases or the production processes of such technologies.

Improved prediction, detection, and treatment approaches for comprehensive stroke management

Code: 30229 | Identifier Code: HORIZON-JU-IHI-2023-05-03 | Programme name: Innovative Health Initiative | Start submission calls: 27/07/2023 | End submission calls: 16/01/2024

Stroke is a preventable, treatable, and manageable disease and thus the potential to reduce its burden and its long-term consequences exists.

The challenge in stroke management is the lack of efficient and comprehensive pathways along the whole continuum of the disease – including the variation of structural settings depending on the location of the patient (rural vs. central) and between countries. The implementation of connected healthcare pathways will lead to an improvement in the outcome for the patients and thereby drive efficiency and effectiveness from a clinical and health resource perspective.

Integrating data is key to allow for modelling, artificial intelligence (AI) and machine learning (ML)-based evaluation to identify groups and individual persons at risk and assure early recognition of stroke, thereby providing faster diagnosis and optimal, patient-specific treatment, resulting in better outcomes for patients. Moreover, comprehensive stroke management continues in the post-acute treatment setting and includes long-term follow-up for secondary prevention and rehabilitation.

Innovative solutions for faster acquisition, integration, and better retention of multiple types of data and better organisation among the various actors across the entire stroke pathway are crucial to achieve optimal prevention and treatment focused on the needs of patients. Use of novel technologies for federated data analytics and interpretation could help in this direction and assist in providing the right treatment to patients in a timely manner, improving their outcomes.

Maximising the potential of synthetic data generation in healthcare applications

Code: 30226 | Identifier Code: HORIZON-JU-IHI-2023-05-04 | Programme name: Innovative Health Initiative | Start submission calls: 27/07/2023 | End submission calls: 16/01/2024

Healthcare research using individual patient data is often constrained due to restrictions in data access because of privacy, security, intellectual property (IP) and other concerns. Synthetic health data, i.e., data that is artificially created to mimic individual patient data, can reduce these concerns, leading to more rapid development of reliable data-driven methods including diagnostic, precision medicine, decision support and patient monitoring tools. However, while many synthetic data generation (SDG) methods are currently available, it is not always clear which method is best for which use case, and SDG methods for some types of data are still immature. Furthermore, it is still unclear whether highly detailed synthetic data, which are often needed for research, can be categorised as anonymous.

This topic is focused on maximising the potential of synthetic data generation in healthcare applications.

Development and proof of principle of new clinical applications of theranostics solutions

Code: 30224 | Identifier Code: HORIZON-JU-IHI-2023-05-02 | Programme name: Innovative Health Initiative | Start submission calls: 27/07/2023 | End submission calls: 16/01/2024

To address this challenge, project(s) funded under this topic should aim at developing new, or innovative combinations of existing multi-modal theranostic solutions including radiopharmaceuticals and/or non- radioactive theranostic solutions. Applicants should clearly identify a disease(s) of unmet public health need, (e.g., oncology, neurology and/or advanced multi-disease conditions) and explain their choice with relevant evidence where possible.

This topic is focused on the development and proof of principle of new clinical applications of theranostics solutions.

Combining hospital interventional approaches to improve patient outcomes and increase hospital efficiency

Code: 25982 | Identifier Code: HORIZON-JU-IHI-2022-03-03 | Programme name: Innovative Health Initiative | Start submission calls: 13/12/2022 | End submission calls: 15/03/2023

Patients admitted to hospital to undergo elective or non-elective procedures typically require recovery and rehabilitation to get back to normal life. New treatment approaches such as minimally invasive surgical approaches, locoregional interventions, novel imaging and diagnostic techniques, clinical decision support systems, and robotics have the potential to reduce complications, facilitate faster recovery, and help increase hospital efficiencies.
Projects funded under this topic should address this challenge by showcasing how existing hospital interventions, treatment approaches and technologies can be optimally combined to improve patient outcomes, enhance patient pathways, generate efficiency gains, reduce hospital staffing challenges, help to lower costs, and decrease societal burden.

Patient-generated evidence to improve outcomes, support decision making, and accelerate innovation

Code: 25980 | Identifier Code: HORIZON-JU-IHI-2022-03-02 | Programme name: Innovative Health Initiative | Start submission calls: 13/12/2022 | End submission calls: 15/03/2023

The amount of health data generated by citizens themselves is rapidly increasing. Such data includes patient-reported outcome measures (PROMs), patient preference information (PPI), and patient-reported experience measures (PREMs), as well as other digital health data/digital biomarkers. These data are often fragmented among multiple providers, so that neither the citizen, nor the healthcare ecosystem have a comprehensive overview, and therefore it is very challenging to fully use these data to provide reliable evidence for decision-makers, and to improve health outcomes.

Strengthening the European translational research ecosystem for advanced therapy medicinal products (ATMPs) for rare diseases

Code: 25978 | Identifier Code: HORIZON-JU-IHI-2022-03-04 | Programme name: Innovative Health Initiative | Start submission calls: 13/12/2022 | End submission calls: 15/03/2023

The overall aim of this topic is to optimise and streamline the future development of ATMPs and other related innovative therapeutic modalities for rare diseases by strengthening the ecosystem that facilitates the transition of early pre-clinical proof-of-concept research to clinical development. This topic focuses on the scientific, technological and regulatory barriers that are limiting translational research into rapid and cost-effective development of ATMPs and other related innovative therapeutic modalities for rare diseases.

Screening platform and biomarkers for prediction and prevention of diseases of unmet public health need

Code: 25976 | Identifier Code: HORIZON-JU-IHI-2022-03-01 | Programme name: Innovative Health Initiative | Start submission calls: 13/12/2022 | End submission calls: 15/03/2023

As the population of the European Union ages, the rising burden of disease is a major challenge to the sustainability and resilience of healthcare systems. The identification of individuals at risk of developing an illness so that they can receive an appropriate treatment before the disease develops is an important factor to address this problem.
Projects funded under this topic should address this challenge by developing an open platform for screening individuals with the aim of identifying people at risk of disease.

Digital health technologies for the prevention and personalised management of mental disorders and their long-term health consequences

Code: 25974 | Identifier Code: HORIZON-JU-IHI-2022-03-05 | Programme name: Innovative Health Initiative | Start submission calls: 13/12/2022 | End submission calls: 15/03/2023

The scope of this topic is to investigate how Digital health technologies DHT might positively impact the healthcare pathway for people with mental disorders.

Setting up a harmonised methodology to promote uptake of early feasibility studies for clinical and innovation excellence in the European Union

Code: 23705 | Identifier Code: HORIZON-JU-IHI-2022-02-02 | Programme name: Innovative Health Initiative | Start submission calls: 28/06/2022 | End submission calls: 20/09/2022

This topic seeks to develop and validate a methodology for EFS that is compliant with EU regulations, including a working methodology, easily accessible online, with information on how to undertake such studies, the process and requirements to follow and fulfil.
It also aims to bring together the relevant stakeholders that could have an interest in EFS and to facilitate use-cases where technologies would run the newly developed EFS methodological framework in order to test it and recommend any adjustments to be made to the methodology.

Cardiovascular diseases - improved prediction, prevention, diagnosis, and monitoring

Code: 23700 | Identifier Code: HORIZON-JU-IHI-2022-02-01 | Programme name: Innovative Health Initiative | Start submission calls: 28/06/2022 | End submission calls: 20/09/2022

The overall aim of the project is to provide tools for the earlier diagnosis of atherosclerosis and heart failure as well as earlier identification of patients at risk. This includes biomarker or predictive algorithms to assess changes in risk and stratify patients according to individual responses to therapeutic intervention.

Next generation imaging and image-guided diagnosis and therapy for cancer

Code: 23698 | Identifier Code: HORIZON-JU-IHI-2022-01-02 | Programme name: Innovative Health Initiative | Start submission calls: 28/06/2022 | End submission calls: 20/09/2022

The specific challenge to be solved by this call topic is to provide early evidence of improved cancer patient care when using next-generation imaging technologies and image-guided solutions as part of combined cancer therapies. An optimised image-based care path from early diagnosis and screening to treatment and follow-up is essential to improve the outcome of cancer patients and help optimise clinical workflows and cancer patients’ journey.

Access and integration of heterogeneous health data for improved healthcare in disease areas of high unmet public health need

Code: 23696 | Identifier Code: HORIZON-JU-IHI-2022-01-04 | Programme name: Innovative Health Initiative | Start submission calls: 28/06/2022 | End submission calls: 20/09/2022

This topic aims to provide a scalable platform for the seamless integration or linkage of these diverse data at scale, and develop tools to allow the data to be used in clinical care, patient self-management and research in disease areas of high unmet public health.

Personalised oncology: innovative people centred, multi-modal therapies against cancer

Code: 23688 | Identifier Code: HORIZON-JU-IHI-2022-01-03 | Programme name: Innovative Health Initiative | Start submission calls: 28/06/2022 | End submission calls: 20/09/2022

The aim of this call topic is biomarker-guided multi-modal precision oncology based on imaging, phenotype, genomics, in vitro diagnostics, co-morbidities, clinical and real-world data.

An innovative decision-support system for improved care pathways for patients with neurodegenerative diseases and comorbidities

Code: 23685 | Identifier Code: HORIZON-JU-IHI-2022-01-01 | Programme name: Innovative Health Initiative | Start submission calls: 28/06/2022 | End submission calls: 20/09/2022

The primary objective of this topic is to develop a decision-support system to enhance medical decisions with targeted clinical knowledge, patient information, and other health information for a more holistic (better integrating diagnosis, treatment and care and breaking silos across specialities) approach to managing and treating patients with a neurodegenerative disease and a comorbid condition, addressing the needs of today, while creating preparedness for a future paradigm-shift in treatment.